Comprehensive industry-specific inspections
Effective validation considering regulations and managing risks
Validation services and GMP expertise for automation projects
Our experienced validation specialists ensure that the machines and production lines we design and build for our clients meet all the requirements set by our clients, and that the risks associated with their use are minimized.
Our validation services cover the entire design and manufacturing process of a machine or production line, from concept development to commissioning.
We have dedicated professionals responsible for validation, but in practice, the entire project team participates in the validation work, ensuring it is comprehensively completed across all aspects of the project.
We also have extensive expertise in GMP (Good Manufacturing Practices), and the projects we carry out are designed and executed in accordance with GMP principles.
This ensures that the machines, production lines, and automation solutions we implement meet the stringent requirements of industries such as pharmaceuticals, including quality control processes, documentation, and risk management.
Examples of our validation-related services
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Our experts analyse the requirements of machines and production lines, ensuring they meet industry standards and regulations.
We have broad knowledge of GMP practices in the pharmaceutical industry, ISO certifications, and the requirements set by the FDA (Food and Drug Administration) and EMA (European Medicines Agency) for food, pharmaceuticals, and healthcare products.
Our validation professionals and the entire project team continuously assess risks related to the machine or production line being built, reducing the likelihood of risks and disturbances in the final machine or production line.
Our validation specialists monitor the design phase of machines and production lines, ensuring that the design meets both customer and industry requirements and is technically feasible.
This helps reduce design errors and improves the quality of the final product.
Validation is also managed in the design and production of prototypes. We ensure that the unique solutions implemented in the machine or production line, such as various new prototypes, meet all necessary standards and regulations.
When conducting FAT and SAT tests for machines and production lines, our validation professionals ensure that the relevant documentation is completed in accordance with standards and regulations.
Our validators perform comprehensive approval and operational validations for machines and production lines.
They ensure that installations are according to instructions, properly documented, and that calibration is done thoroughly.
In addition, validators assess the system’s performance, reliability, and repeatability.
Our validators create all the necessary official documents and reports required during the construction of a machine or production line, which include all stages of the validation process, test results, and evaluations.
These documents serve as a reliable foundation for future audits and periodic inspections.